MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Catalog Number	CP-07811
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer provided four photos for analysis.The photos show the sheath extension with dilator assembly and the dilator hub appears to be separated adjacent to the hub.The customer also returned one, opened cath lab sheath intro set including the sheath extension with an 8fr dilator assembly for analysis.Signs of use were observed.Visual analysis revealed the dilator hub was completely separated from the dilator body.The separation points were rough and discolored.The condition of the separation point appears consistent to that of a stress-related break.No other defects or anomalies were observed.The dilator was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "ensure dilator hub fully snaps into sheath cap." the returned dilator body was removed and reinserted through the hemostasis valve of the sheath.Little to no resistance was observed as the dilator passed completely through the sheath.The dilator body was removed, and the hub was inserted into the cap of the hemostasis valve.The hub was able to snap into the cap and felt secure.A device history record review was per formed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage.Do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary." the customer report of a separated dilator hub was confirmed through complaint investigation of the returned sample.The dilator hub was separated directly adjacent to the body.The material at the points of separation showed white discoloration.This discoloration appeared consistent to that of a stress-related break.A capa was implemented to address the issue of the dilator separation.The capa investigation indicates the root cause was design related.The product from the reported lot was manufactured prior to corrective actions.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the sheath is damaged.The sheath head is broken.They changed to a new one.There was no reported patient harm ".

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20123303
• Report Number: 9680794-2024-00831
• Device Sequence Number: 7399023
• Product Code: DQY
• UDI-Device Identifier: 00801902002150
• UDI-Public: (01)00801902002150(11)220623(17)270531(10)14F22F0115(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CP-07811
• Device Lot Number: 14F22F0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown